Coating composition for skin-contacting surface of elastomeric articles and articles containing the same

ABSTRACT

The invention described herein relates to a therapeutic, moisturizing coating composition for elastomeric articles which is applied directly onto the skin-contacting surface of the article as part of the manufacturing process. The coating composition is thermally stable and subsequently hydrates when contacted with a moisturized skin surface to convert into a liquid “lotion” form during wearing of the article. The coating composition provides therapeutic benefits to the wearer&#39;s skin as a result of wearing the article, such as improved skin moisturization, softness of feel, improved skin elasticity and firmness, and reduced redness and irritation. The invention is particularly useful in medical gloves, including examination and surgical gloves.

RELATED APPLICATION DATA

This application is based on U.S. Provisional Patent Application Ser.No. 60/420,200 filed on Oct. 22, 2002.

FIELD OF THE INVENTION

The invention relates to the field of medical devices. In particular,the invention relates to a coating composition for skin-contactingsurfaces of elastomeric articles.

BACKGROUND OF THE INVENTION

Elastomeric articles which are used in such a manner so as to contactthe wearer's skin are well known. Articles such as medical gloves andcondoms, for example, are anticipated to be worn by the user forextended period of time. Because certain elastomeric articles are usedwith relatively higher frequency as well as with prolonged duration,important characteristics of such articles include their physicalproperties and their comfort of use.

A variety of medical gloves, e.g., surgical gloves and examinationgloves, are well known and readily available in the medical field. Thechemical and physical properties of elastomers used in such gloves havebeen researched, and gloves exhibiting desirable properties inaccordance with their usage have been developed. Properties such astensile strength as elongation modulus, as well as coatings andlubricants, which enhance their usage and/or donning characteristics,have been investigated. A variety of elastomeric polymer compositionshave been examined as well, including formulations using natural andsynthetic latex.

When gloves are worn for extended periods of time, body heat isgenerated by the hand and heavy perspiration that can causeoverhydration damaging the natural skin protection afforded by thestratum corneum. After the gloves are removed from the hand and thesweat evaporates, the skin of the hand can become dry, sensitive andsometimes, infective. Such undesirable skin conditions can lead to evenmore serious skin problems as a result of the loss of epidemical lipidbarrier layer which preserves skin moisture.

Pre-donning skin lotions have been developed for application to theuser's skin prior to donning gloves. Such lotions are typically appliedseparately to the skin, and the glove is then donned afterward. Otherlotions are applied to the skin after the glove has been removed.Therapeutic skin-moisturizing gloves containing water-activatablematerial on a skin-contacting surface are described in Berry U.S. Pat.No. 5,869,072. The water-activatable material disclosed in thisreference includes polyvinyl alcohol, as well as additional ingredientssuch as moisturizers and vitamins and is applied onto a flexible poroussheet which is associated with a glove. Chou U.S. Pat. No. 6,274,154describes an elastomeric glove wherein the skin-contacting surfacecontains an aloe vera coating in the dry state. One problem associatedwith many lotions or creams is the deterioration of glove performance asa result of adverse effects on barrier and physical properties of theelastomer. Another problem associated with pre-coated gloves is theirability to withstand sterilization treatment and/or elevated thermalenvironments, encountered during the manufacturing process and storage,without adverse impact on either the coating, elastomer properties, orboth. Yet another problem with such lotions or creams is the use of oilyemollients, which can produce an uncomfortable greasy feeling.

Certain elastomeric articles, such as surgical gloves, are worn forextended periods of time during medical procedures. The comfort,maintenance of skin moisture, and reduction of skin irritation havebecome of increasing interest in the art. One difficulty associated withdeveloping elastomeric gloves which are both functional and comfortableto the user's skin has been the balancing of their desirable physical(e.g., tactile) attributes in combination with beneficial andtherapeutic results for the user's skin. Even more difficult is theaccomplishment of these physical and comfort characteristics while atthe same time also providing thermal stability and topical therapeuticbenefit.

Accordingly, there is a need in the field of skin-contacting elastomericarticles for improvements in their comfort to the user. Particularlyadvantageous would be the development of an elastomeric glove which ispre-coated with a therapeutic skin care treating composition which isthermally stable. Even more desirable would be such an elastomericcoating layer which provides a non-greasy, comfortable feeling to theskin.

SUMMARY OF THE INVENTION

The invention provides an elastomeric article comprising a therapeuticcoating composition on the skin-contacting surface that can be appliedto the article during its manufacture and subsequently afford acomfortable and therapeutic effect to the wearer's skin whilemaintaining the desirable physical properties of the article. It hasbeen discovered that a coating composition can be developed which iscompatible with medical gloves, is thermally stable, has no substantialadverse effect on its physical properties, has reduced irritation forthe wearer's skin, has a non-sticky and non-greasy feel, has goodsurface-to-skin transference, and has reduced inter-surface andintra-surface tackiness between like elastomeric articles. Particularlysurprising is it has been discovered that not only does the coatingcomposition reduce the adverse effects of wearing elastomeric articlesover time, but it improves the condition of the wearer's skin as aresult of the wear. Even more surprising is that such a formulationcould be developed with a combination of ingredients that can “survive”the conditions of article (e.g., glove) manufacturing processes andequipment, namely the drying or dehydration steps, without significantlydiminishing the beneficial properties of the composition as a result.Elastomeric articles with which the invention can be used includeindustrial gloves, medical gloves (i.e., examination and surgicalgloves), condoms, and the like. The invention is particularly useful inexamination and surgical gloves.

The invention provides a therapeutic coating composition to be appliedto a skin-contacting surface of a skin-contacting elastomeric article,said coating composition comprising a moisturizing agent; and whereinsaid coating composition is applied directly onto said elastomericarticle surface and presented in dry state hydratable form. Thetherapeutic coating composition hydrates upon moisture contact andtransfers onto the wearer's skin during use, providing the topicalbenefits afforded by the ingredients of the composition.

The coating composition provides therapeutic benefit to the wearer'sskin, such as skin moisturization, which is “activated” by moisture onthe wearer's skin. The moisture from the wearer's skin converts thecoating composition into a hydrated, liquid “lotion” form, and the“lotion” form is transferred directly from the skin-contacting surfaceof the article onto the wearer's skin while worn. The coatingcomposition continues to provide prolonged therapeutic benefit to theskin following its removal. The coating composition is chemicallycompatible with the elastomeric materials, and has no substantial impacton the physical properties of the article. The coating composition ofthe invention is thermally stable and survives elevated temperaturesassociated with manufacturing and certain sterilization treatments. Thecoating composition has a pleasant non-sticky, non-greasy feel.Additional ingredients can be combined with the composition of theinvention, such as lubricants, anti-tacking agents, antimicrobial agentsand time release or sustained release agents as well.

An important aspect of the coating composition of the invention is thecollective skin moisturization efficacy of multiple coating compositioningredients. The therapeutic skin properties of the coating compositionare accomplished in part by the discovery that some of the ingredientspossess dual functionalities, wherein at least one of their functions isbeneficial skin moisturization. The moisturizing functionality of thecoating composition is premised upon at least two of the followingmoisturization effects. First, some of the ingredients of thecomposition function as water-soluble moisturizers, such as glycerineand sorbitol. Second, some of the ingredients function as skinpenetrative moisturizers, such as panthenol. Third, some ingredients canfunction as prolonged skin surface moisturizers, such as film-formingpolymers such as chitosan. Furthermore, combinations of the above can beemployed to suit the nature of wear associated with differentelastomeric article types. For example, since examination gloves areworn for relatively shorter time periods, the prolonged skin surfacemoisturizer(s) used can be optional.

The invention provides a coating composition for skin-contactingsurfaces of elastomeric articles comprising at least one polyhydricalcohol moisturizer and at least one alphahydroxy lactone, wherein thecomposition is water-soluble and hydratable upon contact with skin.Preferred polyhydric alcohol moisturizers are glycerol, sorbitol andpantothenol. A preferred alphahydroxy lactone is gluconolactone.

The invention also provides an elastomeric article comprising a coatingcomposition on the skin-contacting surface, the coating compositionbeing in the dry state and comprising at least one polyhydric alcoholmoisturizer and at least one alphahydroxy lactone, wherein thecomposition is water-soluble and hydratable upon contact with skin. Ofparticular interest are elastomeric articles that are typically worn forperiods of time sufficient to allow the coating composition to have itseffect on the wearer's skin, such as examination and surgical gloves.

The invention provides a process for making a skin-contactingelastomeric article providing enhanced therapeutic properties to theskin of the wearer, the process comprising: applying a coatingcomposition to the skin-contacting surface of the elastomeric article,the coating composition comprising at least one polyhydric alcoholmoisturizer and at least one alphahydroxy lactone, wherein thecomposition is water-soluble and hydratable upon contact with skin; anddrying the composition on the skin-contacting surface of the article.The process can be used in the manufacture of examination and surgicalgloves.

The invention further provides a method of therapeutically treating theskin on the hands of an individual in need of said treatment comprisingthe steps of: providing an elastomeric glove comprising a dry-statecoating composition comprising at least one polyhydric alcoholmoisturizer and at least one alphahydroxy lactone, wherein thecomposition is water-soluble and hydratable upon contact with skin;donning the glove on the hand; wearing the glove for a period of timesufficient to permit hydration and transfer of the coating compositiononto the skin surface of the hand; and subsequently removing the glovefrom the hand. The therapeutic treatments include improved skinmoisturization, reduced flaking, softness of feel, improved skinelasticity and firmness, reduced redness and irritation, and reducedappearance of wrinkles.

Additional embodiments and advantages of the invention will becomeapparent from the following description.

DETAILED DESCRIPTION OF THE INVENTION

The term “therapeutic” is meant to refer to the effect of improvingskin-related properties of moisture, elasticity, comfort,non-irritation, preservation of protective skin barrier properties, andthe like.

The term “hydratable” as used herein refers to the property in whichliquids interact with the coating composition to facilitate conversioninto a more liquid form thus facilitating the transfer of thecomposition to the skin. The term is used relative to “dry state”, whichis used herein to indicate the substantial absence of moisture or water.

As used herein, the term “thermally stable” and “thermal stability” whenreferring to the properties of the coating composition of the inventionis meant to indicate that the coating composition in the dry state canwithstand elevated temperatures of about 70° C.

The coating composition according to the invention is adapted forapplication directly onto a skin-contacting surface of an elastomericarticle as part of the manufacturing process. The coating composition ofthe invention is particularly suited for elastomeric articles whichinclude, as part of their anticipated usage, intimate contact with awearer's skin surface and prolonged residence thereon. Suitableskin-contacting elastomeric articles include, but are not limited to,gloves (e.g., industrial, medical and surgical gloves), condoms, fingercots, and the like. Elastomeric articles per se to be treated accordingto the invention can be manufactured using conventional techniques andequipment readily available to those skilled in the art. For example,elastomeric gloves can be made using conventional former-dipping-curingtechniques and equipment, such as that described in Yeh, U.S. Pat. No.6,391,409, the entire text of which is incorporated herein by reference.

Elastomers or elastomeric substrates upon which the coating compositioncan be applied can include any natural or synthetic elastomeric polymerwhich is chemically compatible with the coating composition ingredientsand appropriate for the intended use, e.g., surgical environment.Suitable elastomers include, but are not limited to, synthetic andnatural rubber latex. Natural rubber that can be used includes rubbermade from hevea rubber latex and guayule rubber latex. Synthetic rubberpolymers which can be used include nitrile rubber, polyurethane,polyisoprene, polychloroprene, styrene block co-polymers and polymerblends thereof. Synthetic rubbers that can be used also include acrylicdiene block co-polymerr, acrylic rubber, butyl rubber, EPDM rubber,polybutadiene, chlorosulfonated polyethylene rubber and fluororubber.

One important characteristic of the invention is that the coatingcomposition can be dried directly onto the surface of the article aspart of the manufacturing process. The coating composition is packaged,stored and presented in a dried state on the article surface. Thus, whenin intimate contact with a moisturized skin surface the coatingcomposition converts into a liquid “lotion” form during wear. It isduring this stage that the coating composition transfers and provides aninitial therapeutic and moisturizing benefit to the wearer which remainson the skin surface for a period of time after the article is removed.

Water-soluble moisturizers that can be used in the coating compositioninclude polyhydric alcohol emollients and/or moisturizers. At least onemoisturizer is present, but combinations of two or more moisturizers canbe use as well. Suitable polyhydric alcohol moisturizers that can beused include, but are not limited to, glycerin and sorbitol. Preferably,combination of glycerin and sorbitol is used. An example of glycerin or1,2,3-propanetriol that can be used is Glycon™ G 300 (available fromAldrich Chemical Company, Milwaukee, Wis.). One example of sorbitol orD-glucitol that can be used is available from Aldrich Chemical Company,Milwaukee, Wis.

Water-soluble moisturizer ingredients can be present in an amount up toabout 3.00% by weight of the total composition. Preferably,water-soluble moisturizer is present in an amount ranging from about0.10% to about 1.50%. Glycerin as a water-soluble moisturizer can bepresent individually in an amount ranging from about 0% to about 3.00%by weight, preferably from about 0.10% to about 1.50%. Sorbitol as awater-soluble moisturizer can be present individally in an amountranging from about 0% to about 3.00%, preferably from about 0.10% toabout 1.50% by weight.

Additional moisturizing agents can be used in conjunction with theabove-described polyhydric alcohols. The additional moisturizing agentscan likewise be polyhydric alcohols. Preferably, the composition of theinvention comprises pantothenol or2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutanamide (a.k.a.pro-vitamin B), which, in vivo, increases topical moisture retentionthereby prolonging elasticity and suppleness of the skin, reducesinflammation and irritation of the skin, and stimulates epithelization.Suitable pantothenol for use in the invention is available from AldrichChemical Company, Milwaukee, Wis. and Daiichi Fine Chemicals, Japan, aswell as Ritapan™ DL (available from RITA Corporation, Woodstock, Ill.).

The pro-vitamin B form, pantothenol, is preferred for use in thecomposition. Pantothenoic acid, the acid form of pantothenol, is amember of the B-complex vitamins and is also a structural component ofacyl carrier proteins (ACP) as an essential component of fatty acidsynthetase complex. The stability of pantothenoic acid is, however,highly sensitive to pH fluctuations. The pro-vitamin form pantothenol ispreferred because it is more stable and easily absorbed, and convertsinto the acid form in vivo. Additional moisturizing agents such aspantothenol can be present in an amount ranging from about 0.10 to about3.00%, preferably from about 0.30% to about 0.50% by weight of the totalcomposition.

The coating composition can further comprise a hydroxyacid as a skinexfoliant. Hydroxyacids enhance proliferation of skin cells andincreases ceramide biosynthesis keratinocytes, regulates epidermalthickness and improves desquamation resulting in smoother skin andyouthful appearance. Suitable hydroxyacids that can be used includemonocarboxylic acids, dicarboxilic acids and polyhydroxy acids, andtheir intramolecular lactones, esters and salt forms. Examples ofmonocarboxilic acids include both alpha and beta forms. Gluconolactoneor D-glucono-1,5-lactone is preferred because it provides a therapeuticeffect with relatively less skin irritation. One example ofgluconolactone that can be used is Glucono-delta-Lactone available fromDaniels Archer Midland/DL, United Kingdom or Jungbunzlauer, NewtonCenter, Massachusettes. Hydroxyacid(s) such as gluconolactone can bepresent in an amount ranging from about 0.10% to about 3.00%, preferablyfrom about 0.10% by weight to about 0.50% by weight of the totalcomposition.

A variety of additional functional, therapeutic and cosmetic additivescan be included in the coating composition of the invention as, well,provided they are water-soluble and do not adversely affect the chemicaland physical properties of the composition. Advantageous functionaladditives which enhance the properties of the coating composition thatcan be used in the coating formulation include pH adjusters, anti-tackagents, donning agents and hydration promoters.

Donning agents that can be used include damp donning agents and drydonning agents, and combinations thereof. Damp donning agents that canbe used include quaternary ammonium halide salts which additionallyexhibit antimicrobial properties. A preferred quaternary ammonium halidesalt is cetylpyridinium chloride or 1-hexadecylpyridinium chloride. Oneexample of cetylpyridinium which can be used is CPC available fromZeeland Chemicals, Zeeland, Mich.

Dry donning agents that can be used in the coating composition includesilicone-based compounds, including polyalkylsiloxanes. One example of apolyalkylsiloxane that can be used is polydimethylsiloxane dispersion,such as GE SM 2140™ (available from GE Silicones, Waterford, N.Y.).Other silicone-related dry donning agents can be used that also functionas skin protecting agents as well, such as dimethicone.

Damp donning agents such as cetylpyridinium chloride can be present inan amount ranging from about 0.10% to about 2.00%, preferably from about0.10% to about 1.80% by weight of the total composition. Dry donningagents can be present in an amount ranging from about 0.10% to about8.00%, preferably from about 0.10% to about 0.25% by weight of the totalcomposition.

The coating composition can also include a pH adjuster, which can be aninorganic acid, organic acid, or combination thereof. The amount of pHadjuster to be added will, of course, vary but is preferred that thecompound and amount be selected to adjust the pH value to from about pH4 to about pH 7 range. Preferred are non-irritating pH adjusters, suchas citric acid or 2-hydroxy-1,2,3-propane-tricarboxylic acid, which isavailable from Aldrich Chemical Company, Milwaukee, Wis., for example.The pH adjuster(s) such as citric acid can be present in an amountranging from about 0% to about 0.50% by weight of the total composition.

Anti-tack agents that can be used in the coating composition includesilicones such as silicone oil, silicone resins, silicone gums andsilicone elastomers, cationic polymers such as polydiethyldimethylammonium chloride, fatty acid salts and esters such as potassiumstearate and trimethylolpropane triisostearate, carboxylic ester ofhydroxyalkylamide such as erucamide, fluoro-compounds such as PTFE(polytetrafluoroehtylene) and phosphate salts such as ammonium alkylphosphate (such as Darvan L™ available from R.T. Vanderbilt, Norwalk,Conn.). Anti-tack agent(s) can be present in an amount ranging fromabout 0.25% to about 2.50% of the total weight of the composition.

The coating composition of the invention preferably contains a hydrationpromoter to facilitate uptake and absorption of topical moisture (water)need to “activate” the coating composition. Preferred hydrationpromoters include those which additionally function as buffers to aacidic pH adjuster when present, such as sodium citrate. One example ofsuitable sodium citrate that can be used is sodium citrate or1,2,3-propanetricarboxylic acid trisodium salt, such as sodium citratedihydrate available from Aldrich Chemical Company, Milwaukee, Wis.Hydration promoter(s) such as sodium citrate can be present in an amountranging from about 0% to about 2.00%, preferably from about 0% to about0.50% by weight of the total composition.

Other therapeutic and cosmetic agents can be used as well, such as“anti-aging” compounds. Cosmetic agents that can be used includeretinol, and/or those that can also function as exfoliants, such asalpha hydroxy lactones, such as gluconolactone. Fragrances and coloringagents can also be used in the coating formulation to render thecomposition more appealing to the user.

As a further embodiment, the coating composition can comprise aplasticizer to facilitate uniform distribution of the water-soluble filmforming polymer. Preferred plasticizers include esters such as triethylcitrates, because of its additional chemical function as a buffer in theformulation. One example of suitable triethyl citrate or1,2,3-propanetricarboxylic acid, 2-hydroxy-, triethyl ester is Hydagen™CAT available from Cognis, Cincinnati, Ohio. Plasticizer(s) such asHydagen™ CAT can be present in an amount ranging from about 0% to about1.00%, preferably from about 0% to about 0.50% by weight of the totalcomposition.

In the liquid state prior to application to the surface of theelastomeric article, the coating composition further includes water,preferably deionized water. The initial coating composition is appliedto the surface in liquid state, and can be applied using a variety ofcoating techniques. Suitable coating techniques include dipping andspraying. The coating composition is subsequently dried directly ontothe article surface as part of the manufacturing process. Applicationand drying techniques that can be used in accordance with the inventioninclude the tumbling process and the spraying process.

According to one aspect of the invention, the coating composition isapplied to the article surface and dried directly on the skin-contactingsurface of the article. In general, the coating composition of theinvention can be applied to gloves using the tumbling method or spraymethod. The spraying method is preferred for preparing surgeon's orsurgical gloves. The tumbling method is preferred for preparingexamination gloves. The Examples contain descriptions of each of theseprocesses in greater detail.

The spray method is a process that applies the coating composition ontothe glove using a spraying apparatus. In this process, the gloves areplaced into a tumbler including a spraying device. The coatingcomposition is sprayed in liquid sate in multiple and non-continuoussteps. Heat is applied during spraying and tumbling to dry the lotiononto the glove surface.

Alternatively, the tumbling method is a process that applies the coatingcomposition in liquid state onto the glove surface by placing the glovesinto a tumbler and then filling the tumbler with the coating compositionliquid. The gloves are then tumbled or washed. A tumbling process thatcan be used, for example, can be similar to that described in Chen etal. U.S. patent application Ser. No. 10/666,650 filed Sep. 17, 2003, nowpending.

An important aspect of the coating composition of the invention is thecollective skin moisturization efficacy of multiple coating compositioningredients, and some of the coating composition ingredients of theinvention can possess dual functionality. The humectant functionality ofthe coating composition is premised upon at least two of the followingmoisturization effects. First, some of the ingredients of thecomposition function as water-soluble moisturizers, such as glycerineand sorbitol. Second, some of the ingredients function as skinpenetrative moisturizers, such as pantothenol. Third, some ingredientscan function as prolonged skin surface moisturizers, such asfilm-forming polymers such as chitosan. Furthermore, combinations of theabove can be employed to suit the nature of wear associated withdifferent elastomeric article types. For example, since examinationgloves are worn for relatively shorter time periods, the prolonged skinsurface moisturizer(s) used can be optional.

Variations of the above ingredients and the addition of otheringredients are possible in accordance with the invention, provided thetherapeutic effect of the formulation on the skin is not significantlycomprised. The ingredients of the coating composition, when combined,must be capable of participating in the therapeutic, moisturizing,non-irritating, moisturizing effect on the wearer's skin.

When the elastomeric article is intended for extended wear, such as asurgeon's glove, the coating composition preferably further comprises awater-soluble film forming polymer. Suitable water-soluble, film formingpolymers which can be used include natural or synthetic water soluble,film forming polymers. Preferred are cationic water-soluble film formingpolymers. Suitable film forming polymers which can be used in accordancewith the invention include, but are not limited to, cellulose andcellulose derivatives, polyvinyl pyrrolidone (PVP) and polyvinylpyrrolidone derivatives, and polysaccharrides. Preferably,polysaccharides are used as the water-soluble film forming polymer, andmost preferred as the film forming polymer is chitosan.

Chitosan can be prepared from naturally occurring chitin, which can beobtained from crustacean and insect exoskeletal material. Chitosan isalso referred to as deacetylated chitin, poly-D-glucosamine, poliglusam,beta-1,4-poly-D-glucosamine, and beta-(1,4)-2-amino-2-deoxy-D-glucose.Chitosan and its derivatives can be used in accordance with theinvention. One source of chitosan which can be used is deacetylchitin,available as Hydagen™ CMF from Cognis, Cincinnati, Ohio. When present,film forming polymer(s) such as chitosan can be present in an amount upto 1.00%, preferably ranging from about 0.05% to about 0.20% by weightof the total composition.

Water, preferably deionized water, can be present in an amount rangingfrom about 92% to about 99.5% by weight of the total composition. Totalsolids content of the formulation, or TSC, can also vary from about0.50% to about 8.00%. Overall, variations of the proportions and amountsof the ingredients can be adjusted provided such modifications do notsubstantially compromise the desired properties of the resultingformulation according to the invention.

In another embodiment, particle technology can also be used inconjunction with the coating composition to further enhance thecollective benefits and properties of the invention. In particular,microporous particles can be included in the formulation to provide anumber of additional properties, such as sustained release or timerelease of ingredients. Preferably, the microporous particles that canbe used are those embedded with skin care ingredients that can beincorporated into a powder-free polymer coating. Microporous particletechnology that can be used as a component of the coating composition ofthe invention includes that which is described in U.S. Pat. No. ReissueNo. 33,429, U.S. Pat. No. 4,873,091, U.S. Pat. No. 4,690,825, U.S. Pat.No. 5,028,435, U.S. Pat. No. 5,035,890, U.S. Pat. No. 5,968,543, U.S.Pat. No. 5,955,109, U.S. Pat. No. 5,073,365, U.S. Pat. No. 5,135,740,U.S. Pat. No. 5,145,675, U.S. Pat. No. 5,145,685, U.S. Pat. No.5,156,843, U.S. Pat. No. 5,316,774, U.S. Pat. No. 5,458,890, U.S. Pat.No. 5,840,293, U.S. Pat. No. 5,871,722, and U.S. Pat. No. 5,851,538, theentire texts of which are incorporated herein by reference. Oneparticular microsponge particle of interest is Microsponge 5700(available from Cardinal Health, Inc., Somerset, N.J.), which cancontrollably release particle-absorbed dimethicone by diffusion,moisture, pH, friction, temperature, and/or other active ingredients.

The coating composition of the invention can further contain additionalbeneficial ingredients provided such are chemically compatible with thecomposition of the invention and do not adversely affect the desiredtherapeutic properties of the composition. Additional ingredients thatcan be included in the coating composition include, but are not limitedto, antimicrobial agents, anti-inflammatory agents, topical cleansingagents, anti-perspiration agents, and the like.

The coating composition of the invention can also be applied toelastomeric article surfaces using conventional equipment and techniquesreadily available to those skilled in the field of manufacturingelastomeric articles, including on-line and off-line techniques such asdipping, spraying, tumbling, and the like. For preparing a coatedsurgeon's glove, the preferred method of application is off-linespraying. For the preparation of a coated exam glove, the preferredon-line method of application is dip coating, and the preferred off-linemethod is the tumbling method of coating.

Using a surgeon's glove as an example, the user removes the glove from adispenser or package. Prior to donning the glove, the user typicallyscrubs their hands with surgical scrub solution followed by rinsing withwater. After wiping their hands dry with a sterile towel, the user donsthe glove by placing the hand into the glove such that the glovegenerally conforms to the shape of the user's hand. At this point, thewater-based moisture from the user's skin interacts with the coatingcomposition thereby hydrating the composition and converting it into aliquid “lotion”-type phase. Upon hydration of the coating composition,the comfort and therapeutic benefits such as moisturization of the skin,become realized. Furthermore, after removal of the glove, the coatingcomposition remains on the user's skin thereby providing continuedtherapeutic benefit to the skin.

The following examples further illustrate the invention. Unlessotherwise noted, w/w % is meant to indicate percent dry weight of thetotal weight.

Example 1 Preparation of Coating Composition for Surgical Gloves

A coating composition in accordance with the invention was prepared byinitially determining the amount of each ingredient desired usingconventional ingredient amount calculation methods.

After the amount of ingredients has been determined, the total amount ofwater was added to a beaker and continually stirred as each of theingredients were added. The composition was stirred at ambienttemperature for at least about one hour until a stable, homogenoussolution was formed. The pH and viscosity of the composition weremeasured in accordance with ASTM E70-97 (Standard Test Method for pH ofAqueous Solutions with the Glass Electrode) and ASTM D5225-98 (StandardTest Method for Measuring Solution Viscosity of Polymers with aDifferential Viscometer). Using these methods, the pH was between 4.8and 6.0, and the viscosity was measured at between 15 and 45 cps at roomtemperature using a spindle no. 4 at 60 rpm. The resulting compositionwas then deposited into a glass container and sealed with a lid.

The resulting liquid coating formulation had the following composition:

Formula 1: Amount Ingredient: (w/w %) Chitosan 0.10 Citric acid 0.08Glycerin 0.15 Sorbitol 0.50 Pantothenol 0.30 Gluconolactone 0.15Triethyl citrate 0.30 Cetylpyridinium chloride 1.00 Silicone dispersion0.20 Sodium citrate 0.40 Deionized water 97.22 Total: 100 TSC (totalsolids content) = 2.70%

Chitosan and triethyl citrate were obtained from Cognis, Cincinnati,Ohio. Citric acid, glycerin, sorbitol, pantothenol and sodium citratewere obtained from Aldrich Chemical Company, Milwaukee, Wis.Gluconolactone was obtained from Jungbunzlauer, Newton Center,Massachusettes. Cetylpyridinium chloride was obtained from ZeelandChemicals, Zeeland, Mich. Silicone was obtained from GE Silicones,Waterford, N.Y.

Example 2A Preparation of Coated Glove (Spraying Method)

A surgeon's glove containing a coating composition on theskin-contacting surface can be prepared as follows:

The uncoated glove can be prepared in accordance with conventional gloveforming techniques and equipment. For instance, a former in the shape ofa glove is provided and coated with a coagulant composition andsubsequently dried. The coagulant-coated former is then dipped intopolyisoprene latex to coat the former and the latex is leached withwater, coated with a powder layer and cured on the coated former. Aftercuring, the polyisoprene glove is rinsed, dried and stripped from theformer.

Prior to coating, the gloves can be turned inside-out and pre-rinsed andchlorinated using a chlorinator with chlorine solution with a chlorinestrength of about 300 ppm to about 1000 ppm. After chlorination, thegloves can be post-rinsed prior to coating.

To coat the glove, the chlorinated gloves are removed from thechlorinator, turned inside out such that the skin-contacting surface isexposed and placed in a tumbler equipped with a spray nozzle. The glovesare then dried for a sufficient period of time.

Tumbler design is an important aspect of the preparation of the glovesin order to ensure even uniform coating of the glove surface. Forexample, a drum having a diameter of about 43 inches and a total lengthof about 25 inches can have a total perforated area of about 11.5 inchesand a remaining non-perforated area of about 13.5 inches relative todrum length. The non-perforated area of the drum is determined so thatsome of the gloves to be placed within remain in the non-perforated areafor lubrication and so that suction air flow is reduced in the area. Therevolution speed can vary. For example, a revolution speed ranging fromabout 25 rpm to about 35 rpm can be used, preferably from about 31 rpmto about 32 rpm.

Initial drying can be conducted at a temperature of about 32° C.increasing to about 50° C., for a period of about 15 minutes. The firstspraying can commence after 15 minutes of tumbling. After the firstspraying, the gloves are then tumbled for an additional 60 seconds, andsubjected to a second spraying for about 170 seconds and tumbled againfor an additional 60 seconds thereafter. A third spraying is applied forabout 170 seconds, followed by tumbling at a temperature of about 60° C.for a period of about 2 minutes of cooling. The spraying step can berepeated until the desired amount of coating has been applied to thegloves prior to 25 minutes heat tumbling and 2 minutes cooling cycle.

At the conclusion of the tumbling stage, the gloves can be removed fromthe tumbler for the turning stage. During the turning process, thegloves are manually turned inside out and then subjectwed to the finaldrying at a temperature of about 55 C for a period of about 15 minutes.The gloves are then allowed to cool for a period of about 3 minutes. egloves are then dried at a temperature of about 34° C. for a period ofabout 20 minutes. The gloves containing the coating composition indry-state can then be packaged and sterilized.

Example 2B Preparation of Coated Glove (Tumbling Method)

An examination glove containing a coating composition on thenskin-contacting surface can be prepared as follows:

Prior to coating, the gloves can be post-processed by chlorination.First, the gloves can be turned inside-out exposing the skin-contactingsurface and placed into the chlorinator. The glove can then bepre-rinsed and chlorinated using a chlorinbated solution with a chlorinestrength of about 400 ppm to about 700 ppm. After chlorination, thegloves can be post-rinsed prior to coating.

For coating, the chlorinated gloves can be removed from the chlorinatorand placed into a tumbler for lotion coating and heat drying steps.Excessive water is removed from the gloves by spinning the gloves for aperiod of about 5 minutes. The tumbler is then filled with an aqueouslotion solution such as per Example 3, Formula 2 or Example 4, Formula3. The gloves can then be tumbled in the composition for a period ofabout 10 minutes. The composition can then be drained from the tumbler.

The gloves can then be dried in the tumbler in a heating cycle at atemperature of about 30° C. for a period of about 30 minutes, andsubsequently cooled in a cool-down cycle for a period of about 5minutes. The gloves can then be removed from the tumbler and manuallyturned inside-out. The gloves can then be dried again in a dryer at atemperature of about 60° C. for a period of about 60 minutes and thenallowed to cool to room temperature for about 10 minutes.

In the preparation of coated articles mentioned in the followingexamples, the processes used to prepare coated articles used a processsimilar to Example 2B for examination gloves and Example 2A forsurgeon's gloves. One of ordinary skill in the art can make adjustmentsand modifications to the above process parameters as appropriate forparticular circumstances.

Example 3 Lotion Formulation for Natural Rubber Examination Glove

Formula 2: Amount Ingredient (% w/w) Citric acid 0.10 Glycerin 0.10Sorbitol 0.30 Pantothenol 0.20 Gluconolactone 0.20 Sodium citrate 0.40Silicone dispersion 0.12 Alkyl phosphate ammonium salt 0.74 Water 97.84Total: 100.00 TSC (total solids content, actual) = 2.00%

Citric acid, gluconolactone and sodium citrate were obtained fromJungbunzlauer, Newton Center, Massachusettes. Glycerin and sorbitol wereobtained from Aldrich Chemical Company, Milwaukee, Wis. Pantothenol wasRitapan™ DL obtained from Daiichi Fine Chemical, Japan. Silicone wasobtained from GE Silicones, Waterford, N.Y. Alkylphosphate ammonium saltwas obtained from R.T. Vanderbilt, Norwalk, Conn.

Example 4 Lotion Formulation for Powder-Free Nitrile Examination Glove

Formula 3: Amount Ingredient (% w/w) Citric acid 0.10 Glycerin 0.10Sorbitol 0.30 Pantothenol 0.20 Gluconolactone 0.20 Trisodium Citrate0.40 Silicone dispersion 0.12 Alkyl phosphate ammonium salt 0.48 Water98.10 Total: 100.00 TSC (total solids content, actual) = 1.75%

Citric acid, gluconolactone and trisodium citrate were obtained fromJungbunzlauer, Newton Center, Massachusettes. Glycerin and sorbitol wereobtained from Aldrich Chemical Company, Milwaukee, Wis. Pantothenol wasRitapan™ DL obtained from Daiichi Fine Chemical, Japan. Siliconedispersion used was GE SM2140 @ 50% (liquid) from GE Silicones,Waterford, N.Y. The alkyl phosphate ammonium salt was Darvan™ L @ 80%(liquid) from R.T. Vanderbilt, Norwalk, Conn.

Example 5 Lotion Formulation for Lotion Polyisoprene Surgeon's Gloves

Formula 4: Amount Ingredient: (% w/w) Chitosan 0.10 Citric acid 0.10Glycerol 0.25 Sorbitol 0.75 Pantothenol 0.50 Gluconolactone 0.25Triethyl citrate 0.50 Cetylpyridinium chloride 1.00 Silicone dispersion0.25 Sodium citrate dihydrate 0.40 Alkyl phosphate ammonium salt 1.00Water (soft) 94.90 Total: 100.00 TSC (total solids content, actual) =4.10%

Citric acid, glycerol, sorbitol and sodium citrate dihydrate wereobtained from Aldrich Chemical Company, Milwaukee, Wis. Siliconedispersion used was GE SM2140™ @ 50% (liquid) from GE Silicones,Waterford, N.Y. Gluconolactone was obtained from Daniels Archer Midland,United Kingdom. The alkyl phosphate ammonium salt was Darvan™ L @ 80%(liquid) from R.T. Vanderbilt, Norwalk, Conn. Cetylpyridinium chloridewas CPC from Zeeland Chemicals, Zeeland, Mich. Chitosan (Hydagen™ CMF)and Triethyl citrate (Hydagen™ CAT) were obtained from Cognis,Cincinnati, Ohio. Pantothenol was Ritapan™ DL obtained from Daiichi FineChemical, Japan.

Example 6 Lotion Formulation for Lotion Natural Rubber Surgeon's Gloves

Formula 5: Amount Ingredient: (% w/w) Chitosan 0.10 Citric acid 0.10Glycerol 0.25 Sorbitol 0.75 Pantothenol 0.50 Gluconolactone 0.25Triethyl citrate 0.50 Cetylpyridinium chloride 1.00 Silicone dispersion0.50 Sodium Citrate 0.40 Alkyl phosphate ammonium salt 1.00 Water (soft)94.65 Total: 100.00 TSC (total solids content, actual) = 4.5%

Chitosan (Hydagen™ CMF) and triethyl citrate were obtained from Cognis,Cincinnati, Ohio. Pantothenol was Ritapan™ DL obtained from Daiichi FineChemical, Japan. Citric acid, glycerol, sorbitol and sodium citrate wereobtained from Aldrich Chemical Company, Milwaukee, Wis. Cetylpyridiniumchloride used was CPC from Zeeland Chemicals, Zeeland, Mich. Siliconedispersion used was Silicone SM2140™ from GE Silicones, Waterford, N.Y.Alkyl phosphate ammonium salt used was Darvan L™ available from R.T.Vanderbilt, Norwalk, Conn.

Various factors affect the appropriate amount (load level) of coatingcomposition applied to the glove, such as glove temperature, compositiontemperature, number of sprays, distance of glove from spray nozzle,total solids content of composition. The amount of coating (lotion perglove) can be calculated from total lotion spray and load size (numberof gloves). Sprayer settings also affect the coating process, includingcylinder pressure, liquid pressure, air pressure, and air cap type.Adjustments to appropriate or optimal manufacturing parameters can beselected by those skilled in the glove manufacturing field.

Since the coating composition of the invention is thermally stable,drying and sterilization techniques can be performed on the coatedarticle or glove. As a result of the coating composition being on thearticle surface in the relatively dry state, the composition of theinvention can also accompany the article through certain sterilizationtreatments without significant adverse effects to either the coatingcomposition properties or elastomer physical and barrier properties.Thus, the coating composition, having therapeutic and moisturizingbenefits, can be packaged, stored and initially presented to the user inthe dry state on the article surface. A further benefit associated withthe coating composition is shelf life and storage longevity, since thedry coating formulation is less susceptible to chemical breakdown ordenaturing when stored for relatively extended periods of time.

Therapeutic Effect of Coating Composition:

The follow examples relate to comparative skin property datademonstrating the topical and therapeutic advantages and benefitsassociated with the gloves prepared in accordance with the invention.There are two main collections of comparative studies involving 1)synthetic (nitrile) examination gloves, and 2) synthetic (polyisoprene)surgeon's gloves. Test Article A for synthetic examination glovesevaluation were prepared in accordance with the invention using thecoating composition of Example 4, Formula 3 and applied to the articlesurface using the tumbling method. Test Article A for syntheticsurgeon's gloves evaluation were prepared in accordance with theinvention using the coating composition of Example 5, Formula 4 andapplied to the article surface using the spray method.

Synthetic Examination Gloves I. Clinical Evaluation

Gloves prepared in accordance with the invention were clinicallyevaluated for a variety of skin properties. In each of the followingexamples, two types of gloves were tested. Test Article A was asynthetic Powder-free Nitrile Examination Lotion Glove preparedaccording to the invention using the coating composition as found inExample 4, Formula 3 (TSC=1.75%) and process similar to that of Example2B. Control Test Article B, the comparator glove, was Flexam Nitrile TAmbi™ Glove (available from Cardinal Health, Inc., Dublin, Ohio)untreated with the lotion of the invention. Thirty-one subjects, maleand female, were pre-screened for dry skin on the hands following a36-48 hour “wash out” period, in which the hands were washed daily withNeutrogena® Glycerin Bar and without the use of any moisturizingproducts on their hands. Twenty-six subjects were selected varying inage from 29 to 58 years. No adverse events were reported during thestudy. Each subject was equilibrated in a controlled environment forthirty minutes prior to baseline measurements. Baseline measurementswere taken of the subjects' hands corresponding to the various testingmethods to be applied: NOVA™ meter readings (NOVA™ DPM 9003™, NOVATechnology Corporation, Portsmouth, N.H.) for skin surfacemoisturization; Chroma Meter™ (CR 300™ from Minolta Corporation, NewJersey) readings for skin redness; TEWL (transepidermal water loss)measurements (TewaMeter™ TM 210 Courage, Khazaka Electronic GmbH, Koln,Germany) for barrier function; and D-Squame™ Skin Sampling Discs forskin smoothness and flakiness.

Each of the twenty-six subjects were give one test glove to be worn onone hand, and a comparator glove to be worn on the other hand for twelvesuccessive 15-minute wear periods, with approximate five-minute restperiods between under observation. Subsequent to the final wear period,the subjects had a three-hour rest period and were then equilibrated forthirty minutes. All baseline measurements were repeated on each subject.

Example 7 Comparative Data—Skin Moisturization

The percent change from baseline NOVA™ measurements to final were takenof the subjects using NOVA™ meter readings (NOVA™ DPM 9003™, NOVATechnology Corporation, Portsmouth, N.H.) to evaluate skin surfacemoisturization. The results were averaged for both Test Articles A and Band are set forth in the following table:

TABLE 1 NOVA ™ Percent (%) Change Test Article A Test Article B(control) % Change 12.60% 10.74%

As can be seen from the above data, Test Article A of the inventionexhibited a greater percent NOVA™ change value from baseline of 12.60%as compared to Test Article B, the control value of 10.74%. Accordingly,the glove prepared according to the invention increases skinmoisturization (1.86%) from wear as compared to non-treated gloves.

Example 8 Comparative Data—Dryness

Each of the subjects' hands (dorsal surface) were evaluated for rednessusing a Chroma Meter™ (CR 300™ from Minolta Corporation, New Jersey).Readings were taken for each of test Articles A and Test Articles B. Thereadings for each test article were averaged and are set forth in thefollowing table:

TABLE 2 Chroma-Meter Percent Change Test Article A Test Article B(control) % Change 0.13% 1.27%

The results demonstrate that the Chroma Meter detected almost no changebetween the baseline measurements and final measurements, indicatingthat Test Article A of the invention did not significantly increaseredness on the wearer's skin. Therefore, gloves of the invention causeno significant redness of the wearer's hands, in contrast to untreatedgloves.

Example 9 Comparative Data—Transepidermal Water Loss

The subjects' hands were measured for baseline and final TEWL(transepidermal water loss), the measurements for which were obtainedusing a TewaMeter™ 210 Courage (Khazaka Electronic GmbH, Koln, Germany).The readings were averaged and the percent change calculated from theresulting data, as set forth in the following table:

TABLE 3 TEWL Percent Change Test Article A Test Article B (control) %Change −0.63% −7.18

The above results demonstrate that Test Article B caused significantlygreater transdermal water loss and Test Article A of the invention didnot cause significant water loss during wear time of the gloves. Astransepidermal water loss is correlated to skin barrier protection, thegloves of the invention effectively preserve and maintain the wearer'sprotective skin barrier during use.

Example 10 Flaking Data

Then subjects' hands were evaluated for both fine flaking and coarseflaking, the measurements being obtained using D-Squame™ Skin SamplingDiscs for skin smoothness and flakiness. Desquamation (e.g., peeling,flaking or scaliness) refers to the detachment of cells from theepithelium surface. Dr flaking is measured by D'suame and computerizedimage analysis. The desquamation index (DI) was used to measure overalldryness, and is calculated by the integration of the percent areacovered by scales and their thickness distribution. DI is an indicatorof the status of stratum comeum (SC) hydration. The results aresummarized in the following table:

TABLE 4 Percent Change in Flakiness/Dryness Test Article A Test ArticleB (control) Fine flaking (%   −34% −23.1% difference) Coarse flaking (%  −58%   −60% difference) Overall dryness (% −41.98% −40.0 difference)

As seen in the above data, subjects reported a 34% reduction in fineflaking and a 58% reduction on coarse flaking as a result of wearinggloves prepared in accordance with the invention as compared tountreated gloves. Fine flaking values are regarded as desquamationpotential. Thus, the gloves treated according to the invention providedbetter and durable emollient properties as compared to untreated gloves.

II. Clinical Self-Assessment Study

Thirty subjects, including both males and females, were used for thestudy. The subjects refrained from using any lotions, creams or gels fora period of twenty-four hours prior to the study. The subjects' handswere washed under observation and then provided with the treated nitrileexamination gloves of the invention to be worn for six successive15-minute periods on one hand. A five-minute rest period occurredbetween each 15 minute wear period. The hands wearing the glove werealternated from left to right hands to eliminate positional bias.Questionnaires were administered before and after each 90 minute wearperiod. Twenty-four hours following the glove-wearing, the subjects werequestioned.

Example 11 Skin Moisture

The subjects evaluated skin moisture levels on a scale of 1 through 5(level 1 indicating extremely dry skin/not moist at all, and level 5indicating very moist). Percent change in moisture level was measured atthree main times: before use of glove, after use of glove during study,and 24 hours after use of gloves, with percentages calculated from thetotal of each evaluation score category. The results are set forth inthe following table:

TABLE 5 Skin Moisture Level Results Level Before After After 24 Hours 140%  0%  4% 2 20%  0% 26% 3 33% 20% 70% 4  7% 43%  0% 5  0% 37%  0%

As can be seen from the above data, 100% of the subjects experiencedimprovement in skin moisture. 63% of the subjects experiencedsignificant improvement, i.e., improvement difference of at least twolevels). Gloves prepared according to the invention also produced alasting effect capturing and maintaining moisture level after 24 hours.

Example 12 Redness/Irritation

The subjects evaluated skin redness and irritation levels on a scale of1 through 5 (level 1 indicating no irritation/redness, and level 5indicating very red or irritated). Percent change in redness/irritationlevel was measured at three main times: before use of glove, after useof glove during study, and 24 hours after use of gloves, withpercentages calculated from the total of each evaluation score category.The results are set forth in the following table:

TABLE 6 Skin Redness and Irritation Level Results Level Before AfterAfter 24 Hours 1 50% 94% 87% 2 30%  6% 10% 3 20%  0%  3% 4  0%  0%  0% 5 0%  0%  0%

As can be seen from the above data, the subjects experienced asignificant reduction in redness and irritation. 93% of subjectsreported that redness and irritation had diminished to level 1,corresponding to the complete absence of irritation or redness.

Example 13 Skin Chapping

The subjects evaluated chapped skin levels on a scale of 1 through 5(level 1 indicating no chapping, and level 5 indicating very chapped).Percent change in chapping level was measured at three main times:before use of glove, after use of glove during study, and 24 hours afteruse of gloves, with percentages calculated from the total of eachevaluation score category. The results are set forth in the followingtable:

TABLE 7 Skin Chapping Level Results Level Before After After 24 Hours 117% 70% 80% 2 36% 13%  7% 3 30% 17% 10% 4 17%  0%  3% 5  0%  0%  0%

As can be seen from the above data, the subjects experienced a 67%reduction in chapped skin level.

Example 14 Flaking

The subjects evaluated skin flaking levels on a scale of 1 through 5(level 1 indicating no flaking at all, and level 5 indicating veryflaky). Percent change in flaking level was measured at three maintimes: before use of glove, after use of glove during study, and 24hours after use of gloves, with percentages calculated from the total ofeach evaluation score category. The results are set forth in thefollowing table:

TABLE 8 Skin Flaking Level Results Level Before After After 24 Hours 160% 83% 86% 2 20%  7%  7% 3 20%  7%  7% 4  0%  3%  0% 5  0%  0%  0%

As can be seen from the above data, the subjects experienced a reductionin skin flaking level.

Example 15 Softness

The subjects evaluated skin softness, smoothness and suppleness levelson a scale of 1 through 5 (level 1 indicating not at all soft, smoothsupple, and level 5 indicating very soft, smooth, supple). Percentchange in levels was measured at three main times: before use of glove,after use of glove during study, and 24 hours after use of gloves, withpercentages calculated from the total of each evaluation score category.The results are set forth in the following table:

TABLE 9 Skin Softness Level Results Level Before After After 24 Hours 113%  0%  3% 2 37%  0% 14% 3 44% 10% 52% 4  3% 41% 24% 5  3% 49%  7%

As can be seen from the above data, the subjects experienced an 87%incerase in skin smoothness, softness and supple feel level.

Example 16 Itching

The subjects evaluated skin itch level on a scale of 1 through 5 (level1 indicating not at all itchy, and level 5 indicating very itchy).Percent change in itchiness level was measured at three main times:before use of glove, after use of glove during study, and 24 hours afteruse of gloves, with percentages calculated from the total of eachevaluation score category. The results are set forth in the followingtable:

TABLE 10 Skin Itching Level Results Level Before After After 24 Hours 170% 97% 93% 2 20%  3%  0% 3 10%  0%  7% 4  0%  0%  0% 5  0%  0%  0%

Of the 30% of subjects with some level of itching, had 89% reduction inskin itching level.

Example 17 Skin Texture

The subjects evaluated skin texture levels on a scale of 1 through 5(level 1 indicating not at all firm, and level 5 indicating very firm).Percent change in skin firmness level was measured at three main times:before use of glove, after use of glove during study, and 24 hours afteruse of gloves, with percentages calculated from the total of eachevaluation score category. The results are set forth in the followingtable:

TABLE 11 Skin Firmness Level Results Level Before After After 24 Hours 1 0%  7% 17% 2 13%  7%  7% 3 54% 36% 59% 4 23% 30% 14% 5 10% 20%  3%

As can be seen from the above data, the subjects reported that thegloves of the invention produced firmer skin

Example 18 Visible Fine Wrinkles

The subjects evaluated visible signs of fine wrinkle levels on a scaleof 1 through 5 (level 1 indicating no visible fine wrinkles, and level 5indicating very visible fine wrinkles). Percent change in visible skinfine wrinkling level was measured at three main times: before use ofglove, after use of glove during study, and 24 hours after use ofgloves, with percentages calculated from the total of each evaluationscore category. The results are set forth in the following table:

TABLE 12 Skin Fine Wrinkle Visibility Results Level Before After After24 Hours 1 20% 10% 28% 2 13%  7% 17% 3 20% 27% 42% 4 27% 33% 10% 5 20%23%  3%

As can be seen from the above data, the subjects reported a significantreduction (−50%) of visible fine wrinkles.

Synthetic Surgeon's Gloves

Gloves prepared in accordance with the invention were clinicallyevaluated for a variety of skin properties. In each of the followingexamples, two types of gloves were tested. Test Article A was asynthetic Non-Latex Polyisoprene Powder-free Surgical Glove with Lotion(Esteem™) prepared according to the invention using the coatingcomposition of Example 5, Formula 4 (TSC 4.10%) and process similar tothat of Example 2A. Control Test Article B, the comparator glove, was aNon-Latex Polyisoprene Powder-free Surgical Glove (Esteem™) (availablefrom Cardinal Health, Inc., Dublin, Ohio). Twenty-nine subjects, maleand female, were pre-screened for dry skin on the hands following a36-48 hour “wash out” period, in which the hands were washed daily withNeutrogena® Glycerin Bar and without the use of any moisturizingproducts on their hands. Twenty-five subjects were selected varying inage from 27 to 59 years. No adverse events were reported during thestudy.

Each subject was equilibrated in a controlled environment for thirtyminutes prior to baseline measurements. Baseline measurements were takenof the subjects' hands corresponding to the various testing methods tobe applied: NOVA™ meter readings (NOVA™ DPM 9003™, NOVA TechnologyCorporation, Portsmouth, N.H.) for skin surface moisturization; TEWL(transepidermal water loss) measurements (TewaMeter™ TM 210Courage+Khazaka Electronic GmbH, Koln, Germany) for barrier function;Cutometer™ MPA 580 (Courage+Khazaka Electronic GmbH, Koln, Germany)meaurements to assess skin elasticity; Replica® locators (Cuderm,Dallas, Tex.) and SILFLO™ Resin, from Flexico, Davis HealthcareServices, Ltd., Hertz, England) for measurement of fine lines andwrinkles.

Each of the twenty-five subjects were given the test glove to wear onone hand and a control glove for the contra hand for three one-hour wearperiods. Two five minute rest periods were given between the first twoone-hour periods. After the final one-hour wear period, the subjectswere equilibrated again in a controlled environment room for thirtyminutes. All measurements taken at the baseline period were taken again(final measurements).

Example 19 Comparative Data—Moisturization

Baseline and final NOVA™ meter readings (NOVA™ DPM 9003™, NOVATechnology Corporation, Portsmouth, N.H.) were measured for both testArticles to evaluate skin surface moisturization. The measurements wereused to calculated percent change. The results are summarized in thefollowing table:

TABLE 13 NOVA Percent Change Test Article A Test Article B (control) %Change 9.74% 6.34%

As can be seen from the above results, Test Article A of the inventionproduced a 54% greater increase in skin moisture from baseline to finalmeasurement readings as compared to Test Article B.

Example 20 Comparative Data—Skin Barrier Maintenance

Transepidermal water loss (TEWL) baseline and final measurements foreach Test Article were taken using a TewaMeter™ TM 210 Courage+KhazakaElectronic GmbH, Koln, Germany) in order to evaluate skin barrierfunction. Percent change was calculated from the measurements, theresults of which are summarized in the following table:

TABLE 14 TEWL Percent Change Test Article A Test Article B (control) %Change 4.87 12.37

As can be seen from the above results, Test Article B caused an increasein transepidermal water loss of 154% over Test Article A of theinvention from baseline to final readings. This indicates thatsignificantly less skin barrier function deterioration occurs in theglove of the invention as compared to untreated gloves.

Example 21 Comparative Data—Elasticity

Two elasticity parameters were measured by Cutometer™ MPA 580(Courage+Khazaka Electronic GmbH, Koln, Germany) for each of TestArticle A to Test Article B. The first parameters is R6, which is aratio of viscoelastic deformation (Uv) to elastic deformation (Ue),measuring overall elasticity, associated with viscoelastic parametersindependent of skin thickness. The second parameter is Ue, whichmeasures elastic deformation, associated with immediate distension.Percent change of R6 and Ue were calculated, and the results aresummarized in the following tables:

TABLE 15 R6 Percent Change Test Article A Test Article B (control) %Change −1.28% 12.35%

TABLE 16 Ue Percent Change Test Article B Test Article A (control) %Change 31.45% 11.15%

The above data demonstrates a decrease in R6 value for Test Article A,as opposed to an increase for control Test Article B. As can also beseen, Test Article A produced an Ue increase 2.8 times greater than theincrease produced by test Article B. Collectively, the decrease in R6value and corresponding increase in Ue value demonstrate that afterwearing the gloves prepared in accordance with the invention, thewearer's skin exhibits improved skin elasticity properties as comparedto untreated gloves.

Example 22 Comparative Data—Visible Lines and Creases

Replica® locators (Cuderm, Dallas, Tex.) and SILFLO™ Resin, fromFlexico, Davis Healthcare Services, Ltd., Hertz, England) were used tomeasure fine lines and wrinkles on the skin surface of the subjects. Thedata has been summarized and is set forth in the following table:

TABLE 17 Comparative Replica Image Analysis of Polyisoprene SurgicalGlove Test Article A Test Article B FNUM initial 0.946 0.998 FNUM final1.028 0.891 FNUM change 0.081 0.106 P(t) 0.1457 0.0333

The above data demonstrates that Test Article B produced significantincrease in lines and wrinkles as measured by FNUM values as compared totest Article A. In conclusion, lotioned gloves prepared according to theinvention exhibit significantly reduced fine line and wrinkle appearanceas compared to gloves without lotion.

The above clinical data demonstrates the improvements associated withthe wearing of gloves of the invention. More specifically, glovesprepared in accordance with the invention provide collective therapeuticenhancements to the wearer's skin. These therapeutic enhancementsinclude short and long term skin moisture retention, reductions inirritation and redness, flaking, maintenance of skin barrier function,and noticeable skin softness. These attributes can be provided to theuser's hands without compromising the functionality of the glovescritical to their use.

INDUSTRIAL APPLICABILITY

The invention provides a coating composition for the skin-contactingsurfaces of elastomeric articles which provide beneficial therapeuticskin treatment to the wearer's skin. The advantages afforded by theinvention are particularly useful in elastomeric articles which areassociated with prolonged periods of wear, such as surgical gloves,where deterioration of beneficial skin properties can occur as a resultof such prolonged wear. Elastomeric articles made according to theinvention can be used in a variety of contexts in addition to themedical field, such as food preparation or cosmetic usage environments.Accordingly, gloves made according to the invention not only reduce theadverse effects on the wearer's skin typically associated withelastomeric gloves worn for long periods of time, but improve thecondition of the wearer's skin.

The invention has been described herein above with reference to variousand specific embodiments and techniques. It will be understood by one ofordinary skill in the art, however, that reasonable variations andmodifications of such embodiments and techniques can be made withoutsubstantially departing from either the spirit or scope of the inventionas defined by the claims set forth below.

What is claimed is:
 1. An elastomeric article comprising: an elastomericlayer having a skin-contacting elastomeric surface; and a coatingcomposition provided directly on substantially the entireskin-contacting elastomeric surface of said elastomeric layer, saidcoating composition being in a dry state and comprising: a) at least onepolyhydric alcohol moisturizer, wherein polyhydric alcohol moisturizersare present in a combined amount ranging from about 30% to about 37% ofthe total solids content of the coating composition; and b) at least onealphahydroxy lactone in an amount ranging from about 5% to about 12% ofthe total solids content of the coating composition; wherein saidcomposition is water-soluble and hydratable upon contact with skin. 2.The elastomeric article according to claim 1 wherein the elastomericlayer is composed of natural rubber.
 3. The elastomeric articleaccording to claim 1 wherein the elastomeric layer is composed ofsynthetic rubber.
 4. The elastomeric article according to claim 3wherein the synthetic rubber is nitrile rubber.
 5. The elastomericarticle according to claim 3 wherein the synthetic rubber ispolyisoprene.
 6. The elastomeric article according to claim 1 whereinsaid article is an examination glove.
 7. The elastomeric articleaccording to claim 1 wherein said article is a surgeon's glove.
 8. Theelastomeric article according to claim 1 wherein said at least onepolyhydric alcohol moisturizer comprises pantothenol in provitamin Bform.
 9. The elastomeric article of claim 8, wherein pantothenol ispresent in an amount ranging from about 10% to about 13% of the totalsolids content of the coating composition.
 10. The elastomeric articleaccording to claim 1 wherein said at least one alphahydroxy lactone isgluconolactone.
 11. The elastomeric article according to claim 10wherein said gluconolactone is D-glucono-1,5-lactone.
 12. Theelastomeric article according to claim 1 wherein said at least onepolyhydric alcohol moisturizer comprises pantothenol in combination withat least one of glycerin and sorbitol.
 13. The elastomeric articleaccording to claim 1 wherein said coating composition further comprisesa water-soluble film-forming polymer.
 14. The elastomeric articleaccording to claim 13 wherein said water-soluble film-forming polymercomprises chitosan.
 15. The elastomeric article according to claim 1,wherein the coating composition further comprises a hydration promoter.16. The elastomeric article according to claim 1, wherein the coatingcomposition further comprises a plasticizer.
 17. The elastomeric articleaccording to claim 1, wherein prior to application to the elastomericarticle, said coating composition comprises: a) water-soluble polyhydricalcohol moisturizer present in an amount up to about 3.00% by weight ofthe total composition; and b) alphahydroxy lactone present in an amountranging from about 0.10% to about 3.00% by weight of the totalcomposition.
 18. The elastomeric article of claim 1, wherein one of theat least one polyhydric alcohol moisturizers comprises glycerin in anamount ranging from about 5% to about 7% of the total solids content ofthe coating composition.
 19. The elastomeric article of claim 1, whereinone of the at least one polyhydric alcohol moisturizers comprisessorbitol in an amount ranging from about 15% to 19% of the total solidscontent of the coating composition.
 20. An examination glove comprising:an elastomeric layer having a skin-contacting elastomeric surface; and acoating composition provided directly on substantially the entireskin-contacting elastomeric surface of said elastomeric layer; saidcoating composition being in a dry state and comprising: a) at least onepolyhydric alcohol moisturizer, wherein polyhydric alcohol moisturizersare present in a combined amount ranging from about 30% to about 37% ofthe total solids content of the coating composition; and b) at least onealphahydroxy lactone in an amount ranging from about 5% to about 12% ofthe total solids content of the coating composition; wherein saidcomposition is water-soluble and hydratable upon contact with skin. 21.The examination glove of claim 20, wherein one polyhydric alcoholmoisturizer of said at least one polyhydric alcohol moisturizer ispresent in an amount ranging from about 5% to about 19% of the totalsolids content of the coating composition.
 22. A surgeon's glovecomprising: an elastomeric layer having a skin-contacting elastomericsurface; and a coating composition provided directly on substantiallythe entire skin-contacting elastomeric surface of said elastomericlayer; said coating composition being in a dry state and comprising: a)at least one polyhydric alcohol moisturizer, wherein polyhydric alcoholmoisturizers are present in a combined amount ranging from about 30% toabout 37% of the total solids content of the coating composition; and b)at least one alphahydroxy lactone in an amount ranging from about 5% toabout 12% of the total solids content of the coating composition;wherein said composition is water-soluble and hydratable upon contactwith skin.
 23. The surgeon's glove according to claim 22, wherein saidcoating composition further comprises chitosan.
 24. The surgeon's gloveof claim 22, wherein one polyhydric alcohol moisturizer of said at leastone polyhydric alcohol moisturizer is present in an amount ranging fromabout 5% to about 19% of the total solids content of the coatingcomposition.
 25. The surgeon's glove according to claim 24, wherein saidcoating composition further comprises chitosan.
 26. An elastomericarticle comprising: an elastomeric layer having a skin-contactingelastomeric surface; and a coating composition provided directly onsubstantially the entire skin-contacting elastomeric surface of saidelastomeric layer, said coating composition being in a dry state andcomprising: a) at least one polyhydric alcohol moisturizer, wherein onepolyhydric alcohol moisturizer of said at least one polyhydric alcoholmoisturizer is present in an amount ranging from about 5% to about 19%of the total solids content of the coating composition, and whereinpolyhydric alcohol moisturizers are present in a combined amount rangingfrom about 30% to about 37% of the total solids content of the coatingcomposition; and b) at least one alphahydroxy lactone in an amountranging from about 5% to about 12% of the total solids content of thecoating composition; wherein said composition is water-soluble andhydratable upon contact with skin.
 27. The elastomeric article accordingto claim 26 wherein the elastomeric layer is composed of natural rubber.28. The elastomeric article according to claim 26 wherein theelastomeric layer is composed of synthetic rubber.
 29. The elastomericarticle according to claim 28 wherein the synthetic rubber is nitrilerubber.
 30. The elastomeric article according to claim 28 wherein thesynthetic rubber is polyisoprene.
 31. The elastomeric article accordingto claim 26 wherein said article is an examination glove.
 32. Theelastomeric article according to claim 26 wherein said article is asurgeon's glove.
 33. The elastomeric article according to claim 26wherein said at least one polyhydric alcohol moisturizer comprisespantothenol in provitamin B form.
 34. The elastomeric article of claim33, wherein pantothenol is present in an amount ranging from about 10%to about 13% of the total solids content of the coating composition. 35.The elastomeric article according to claim 26 wherein said at least onealphahydroxy lactone is gluconolactone.
 36. The elastomeric articleaccording to claim 35 wherein said gluconolactone isD-glucono-1,5-lactone.
 37. The elastomeric article according to claim 26wherein said at least one polyhydric alcohol moisturizer comprisespantothenol in combination with at least one of glycerin and sorbitol.38. The elastomeric article according to claim 26 wherein said coatingcomposition further comprises a water-soluble film-forming polymer. 39.The elastomeric article according to claim 38 wherein said water-solublefilm-forming polymer comprises chitosan.
 40. The elastomeric articleaccording to claim 26, wherein the coating composition further comprisesa hydration promoter.
 41. The elastomeric article according to claim 26,wherein the coating composition further comprises a plasticizer.
 42. Theelastomeric article according to claim 26, wherein prior to applicationto the elastomeric article, said coating composition comprises: a)water-soluble polyhydric alcohol moisturizer present in an amount up toabout 3.00% by weight of the total composition; and b) alphahydroxylactone present in an amount ranging from about 0.10% to about 3.00% byweight of the total composition.
 43. The elastomeric article of claim26, wherein one of the at least one polyhydric alcohol moisturizerscomprises glycerin in an amount ranging from about 5% to about 7% of thetotal solids content of the coating composition.
 44. The elastomericarticle of claim 26, wherein one of the at least one polyhydric alcoholmoisturizers comprises sorbitol in an amount ranging from about 15% to19% of the total solids content of the coating composition.